Implantswiss

Basic Information

• Brand Name: Implantswiss
• Primary DI: 07640168183387
• Version / Model: S-TShA
• Catalog Number: S-TShA
• Company Name: Novodent SA
• Labeler DUNS: 480055352
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 3
• Public Version Date: 2021-05-24
• Public Version Status: Update
• Public Device Record Key: 2a256093-c584-4575-af54-20282f1ffc82
• Distribution End Date: 2021-03-31

Device Description

Tissue Level Shoulder Analog

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640168183387	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from light and sun